390 North Orange Avenue, Suite 2300 | Orlando, FL 32801 | United States
+1 855-510-2240
FDA SERVICES
FDA REGISTRATION SERVICES

ITB HOLDINGS LLC provides FDA REGISTRATION and COMPLIANCE SERVICES to domestic and foreign manufacturers, exporters, warehouses, importers, or distributors of food products, dietary supplements, canned foods, cosmetics, drugs or medical devices.

Most Food Facility Registrations are completed within 72 hours. Same Day Service is also available, when needed and requested.

Join our satisfied clients in 100 countries including China | Japan | South Korea | Germany | France | United Kingdom | Canada | Mexico | Russia | Brazil | Spain | Netherlands | Belgium | Sweden | Denmark | Australia | Ireland | Poland | Czech Republic | United States.

Your Canadian, Mexican, Brazilian, Australian, Indian, Chinese, South Korean, Japanese, Russian, Italian, Greek, Portuguese, French, Belgian, Dutch, German, Swiss, Swedish, British, Irish Facility or Establishment must have a DUNS Number and FDA Registration Number.

FDA REGISTRATION REQUIREMENT

Companies can export or import food products, dietary supplements or dietary ingredients to or from the United States, as long as the facilities that produce, store, or otherwise handle the products, are registered with the Food and Drug Administration (FDA), and prior notice of incoming shipments is provided to the FDA.

Offering an article that is a drug or medical device for import without establishment registration, is illegal. Even when a Premarket Notification 510(k) is not required, it is necessary to meet other requirements.

Domestic and foreign establishments that manufacture, repack, or re-label animal food or drug products are required to register with the FDA.

All drug and medical device manufacturers, repackers or re-labelers are also required to list all of their commercially marketed products.

LOW FDA REGISTRATION SERVICE FEES
  • Food Facility
  • Dietary Supplements Facility
  • Food Canning Establishment (FCE)
  • OTC Drug Establishment
  • Prescription Drug Establishment
  • Medical Devices Establishment
  • Cosmetics Establishment
  • Label Review
  • Foreign Supplier Verification Program (FSVP) Importer
  • Prior Notice
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T : +1 855 510 2240
T : +1 855 389 7344
T : +44 800 610 1577

Skype : itbholdings

CONTACT ITB HOLDINGS LLC